Large-Scale AAV Manufacturing: From Concept To Ready-To-Use Platform

Adeno-associated viral (AAV) vectors are replication-defective, single-stranded DNA parvoviruses that possess a number of advantages for the manufacture of advanced therapies. AAV vectors demonstrate high transduction efficiency across a wide range of dividing and quiescent target cells, and produce a weak immune response when compared to Adenoviruses. Their lack of pathogenicity and toxicity, long-term transgene expression, and safety profile make AAVs an attractive option for producing viral vectors for advanced therapies.

Despite the advantages conferred by AAV vectors, large-scale AAV manufacturing remains inconsistent in the cell and gene space, hindered by complexities related to the scale-up of certain parameters, as well as limited cloning capacity and the potential for humoral immune response. Surmounting some of the challenges related to AAV manufacturing and scale-up represent an important opportunity for the space; finding the right partner to facilitate projects involving AAV vectors hinges on identifying experience, expertise, and capacity.

AGC Biologics, a global, end-to-end contract development and manufacturing organization (CDMO), possesses more than 25 years of experience in the cell and gene therapy space. Currently, AGC is working to develop independent, innovative processes in-house for producing high-quality, high-productivity AAVs. In a recent webinar, “Large-Scale AAV Manufacturing: From Concept to Ready-to-Use Platform,” experts from AGC and one of its partners outlined the characteristics and approaches that distinguish it from other CDMOs in the AAV manufacturing space.